CLASS II Device recall · Reported 2 Mar 2022 · FDA Enforcement Report

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma Long recalled

Biomet is recalling Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma Long, distributed nationwide in the US. The recall was initiated on 7 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: 994800 UDI:(01)00880304462632(17)290816(10)994800

Quantity recalled9 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0676-2022
FDA event ID: 89544
Recalling firm: Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 7 Jan 2022
FDA classified: 24 Feb 2022
Reported: 2 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

7 Jan 2022	Recall initiated by company
24 Feb 2022	Classified by FDA	+48 days
2 Mar 2022	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The products in scope underwent an incorrect rework operation for the porous plasma sprayed coating. Internal testing indicated that the parts may not have sufficient adhesion strength. The scope was identified to be all lots that were porous plasma coated or recoated at a vendor that were then reworked through the internal waterjet rework process. The waterjet rework process for porous plasma coating is not validated for products that were coated at a vendor.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma, 13 MM, 83 MM Long Item Number: 113633

Where it was distributed

Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.

Nationwide

Questions about this recall

Is Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma Long recalled?

Yes. Biomet recalled Comprehensive Shoulder System Mini Humeral Stem, Porous Plasma Long on 7 Jan 2022. The recall is Class II and its status is Terminated. Recall number Z-0676-2022.

Why was it recalled?

Which lots are affected?

Lot Number: 994800 UDI:(01)00880304462632(17)290816(10)994800

Where was it sold?

Worldwide distribution - US Nationwide and the countries of Canada, Ecuador, Netherlands.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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